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Sr Principal Scientist - Analytical Chemistry (Synthetic Programs)

Employer
Amgen
Location
Thousand Oaks, CA
Start date
Aug 9, 2022
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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Amgen is currently seeking a Process Development Senior Principal Scientist Attribute Sciences in Thousand Oaks, CA.

SR PRINCIPAL SCIENTIST ANALYTICAL CHEMISTRY (SYNTHETIC PROGRAMS)

Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including synthetic medicines, monoclonal and bi-specific antibodies, bi-specific T-cell engagers (BiTEs), and live oncolytic viruses. This role primarily focuses on synthetic, and particularly, oligonucleotide (siRNA) modalities.

Located in our Thousand Oaks, CA headquarters, the PD Senior Principal Scientist will work to provide strategic analytical leadership to Pivotal Attribute Sciences teams focusing on synthetic products to develop commercializable manufacturing processes and control strategies and collaborate closely with functions including Drug Substance, Drug Product, Quality, Regulatory Affair, Contract development and Manufacturing colleagues.

Role Responsibilities:

  • Be responsible for analytical control strategy including analytical characterization of oligonucleotide, method development for in-process control, release and stability testing methods of starting materials, sense strand, antisense strand, SiRNA drug substance, SiRNA drug product, method validation, impurity characterization, release testing and stability of oligonucleotide drug substance and drug product.

  • Serve the role of an ASTL and/or provide mentorship to ASTLs who are responsible for development of analytical control strategy and analytical support for synthetic Drug Substance (DS) and Drug Product (DP) through commercial process development to commercialization, i.e. process performance qualification.

  • Group leader handling Attribute Sciences Team leads (ASTLs) and staff in support of pivotal phase process development. Provide mentorship to the team members including analytical process development and coordinated control strategy of synthetic products, career development, etc.

  • Handle resources including teams, group members, and instrumentation to support process development.

  • Provide analytical support and mentorship on a range of analytical work packages including but not limited to strategies for reaction monitoring, starting materials and drug substance intermediates quality control, DS and DP release and stability.

  • Understand analytical methodologies to support oligonucleotide purity and impurity analysis using a variety of techniques including but not limited to UV-Vis spectroscopy, chromatography, electrophoresis (slab gel and capillary format) and mass spectrometry.

  • Chemical sequencing and experience in high resolution mass spectrometry is a plus.

  • Responsible to define the analytical target profile (ATP) for methods used to control product quality. Based on the ATP, lead all aspects of the development, qualification, optimization, validation and transfer of analytical methods to Quality Control or external Contract Manufacturing Organization (CMO).

  • Partner with Contract Manufacturing function to handle external activities at contract manufacturing and testing sites

  • Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents and respond to analytical and product quality questions from health authorities.

  • Drive product characterization in support of process comparability studies, regulatory filings, regulatory inquiry, and reference standard qualification

  • Provide expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development

  • Define strategies that improve the effectiveness and efficiency of the Attribute Sciences department

Basic Qualifications:

  • Doctorate degree and 3 years of demonstrated ability OR

  • Masters degree and 6 years of demonstrated ability OR

  • Bachelors degree and 8 years of demonstrated ability

Preferred Qualifications:

  • Advanced degree in Analytical Chemistry, Organic Chemistry, Material Science or related area.

  • 4+ years of experience in the pharmaceutical process development with related experience in leading the analytical team through clinical phases and commercialization of oligonucleotide products.

  • 10+ years of experience in the pharmaceutical process development with related experience in leading the analytical team through clinical phases and commercialization of synthetic products.

  • Strong understanding of oligonucleotide analysis including chromatographic and spectroscopic techniques with an emphasis toward process understanding and process control, separation science, structure elucidation

  • In-depth understanding of analytical methodologies to support oligonucleotide purity and impurity analysis including denaturing and nondenaturing purity analysis, counter ion analysis, and structural elucidation using a variety of techniques including but not limited to UV-Vis spectroscopy, reversed phase chromatography, ion pairing chromatography, anion exchange chromatography, and mass spectrometry.

  • Chemical sequencing and experience in high resolution mass spectrometry is a plus.

  • Candidate must have a strong background in organic chemistry. Experience in solid and solution phase chemistry is a plus.

  • Ability to develop, qualify, transfer and remediate methods for in-process, release and stability testing

  • Experience in analytical testing requirements for immediate release and controlled release solid dosage forms, sterile liquid formulation or lyophilized formulation

  • Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development, etc.

  • Understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner

  • Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, handling results against timelines

  • Good communication skills and ability to provide cross-functional leadership and mentorship to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams, e.g. advising and defending the Quality Target Product Profile

  • Works well in cross-functional teams, and across various geographic locations in different time zones

  • Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

  • A self-starter and phenomenal teammate with strong leadership and decision-making skills, who can provide mentorship to junior staff

  • Ability to multitask, optimally plan and follow through on projects

  • Someone who strongly values working on and leading teams

THRIVE

WHAT YOU CAN EXPECT OF US

As we work to develop treatments that look after others, so we work to care for our teammates professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization

  • Diverse and expansive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

APPLY NOW FOR A CAREER THAT DEFIES CREATIVITY

In our quest to serve patients above all else, Amgen is the first to invent, and the last to doubt. Join us.


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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